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NCT00125827 · ClinicalTrials.gov registry record · Phase 1
Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00125827 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants.
The verdict
NCT00125827, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions: 1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days? 2. What are the side effects of clofarabine when given on this schedule? 3. How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? 4. Will oral clofarabine help treat solid tumor cancer?
Interventions
- DRUG clofarabine (oral formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-10 |
| Est. Completion | 2006-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125827
The ClinicalTrials.gov registry entry for NCT00125827 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which clofarabine (oral formulation) is the first listed.
NCT00125827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00125827 about?
NCT00125827 is a clinical study titled "Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors". Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a research study of clofarabine that will be given to pa...
What is the current status of trial NCT00125827?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2003-10. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00125827?
The interventions under investigation include: clofarabine (oral formulation) (DRUG).
Who is sponsoring clinical trial NCT00125827?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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